Field of the Invention
The present invention is directed to a fluid collection assembly and methods for use thereof and more particularly, to a fluid collection assembly including a breakable plunger rod for use in arterial blood collection. The present invention is also directed to a fluid collection assembly configured for containing an anti-coagulant for the immediate association with a fluid sample upon collection of the sample.
Description of Related Art
Arterial blood collection syringes are used for withdrawing and collecting arterial blood samples from the body of a patient. Once the blood sample is collected, it is subjected to diagnostic analysis for gases, electrolytes, metabolites, and other elements that are indicative of a condition of a patient. Various types of syringes have been devised for collecting arterial blood samples, which mainly comprise elements from a hypodermic syringe, i.e., a plastic or glass syringe barrel, a sealing elastomeric stopper, and a plunger rod. Additionally, certain arterial blood collection syringes include a self-sealing filter that allows passage of air out of the syringe during blood collection, while still preventing the passage of blood. This latter type of syringe having a filter allows for an arterial sample to be collected without the need to aspirate the syringe, as is required with a syringe having a plunger rod and a plunger stopper.
Typical arterial blood collection syringes include a two-piece plunger rod assembly comprised of an elastomeric sealing stopper attached to a plunger rod. U.S. Pat. No. 5,314,416 to Lewis et al. discloses a low friction syringe assembly having a typical two-piece plunger rod and a plunger tip assembly. The sealing stopper and plunger rod must be assembled together in a separate operation prior to assembly with a syringe barrel. In addition, a silicone lubricant is usually used on the interior wall of the syringe barrel to facilitate easy slidable movement of the elastomeric sealing stopper against the interior wall of the syringe barrel. Such syringes typically involve an active step for obtaining a blood sample. For example, a needle connected to such a syringe accesses a patient's blood vessel, and the syringe is thereafter aspirated by the user holding the syringe with one hand and drawing the plunger rearwardly within the syringe barrel with the other hand so as to draw a blood sample into the syringe barrel for analysis. The need for the user to use two hands during the blood sample collection introduces unnecessary movement during the blood draw process and might cause discomfort to the patient.
Arterial blood samples can also be obtained passively through the use of a syringe having a plunger with a porous filter to collect blood by way of the blood pressure of a patient from whom the blood is being collected. In such a syringe, the plunger mechanism is typically hollow, and includes a porous filter therein. A separate elastomeric sealing stopper is typically attached to the front end of the plunger mechanism for sealing within the syringe barrel, with air channels in the stopper for air passage through the filter. In use, the plunger is set at a certain position against a graduated scale of the syringe barrel, so that the desired volume of the sample to be collected is represented by the cavity within the syringe. Once a blood vessel of a patient is accessed by an appropriate needle attached to the syringe, arterial blood will fill the syringe under its own pressure. As the cavity within the syringe fills, air within the syringe is allowed to escape from the syringe by way of a gas permeable filter. When the blood sample contacts the filter, the filter seals, thereby preventing escape of blood and ingress of air and other contaminants into the collected sample. U.S. Pat. No. 4,821,738 to Iwasaki et al. discloses an arterial blood gas syringe including a typical two-piece assembly for use. The arterial blood gas syringe is comprised of a plunger rod and an elastomeric sealing plug having channels formed in an upper surface for use in removing air as arterial blood is received in the syringe. The channels extend in a generally radial direction and converge near the center of a sealing plug to allow the passage of air to and through a filter element contained within the sealing plug. U.S. Pat. Nos. 5,377,689 and 5,529,738, both to Mercereau, disclose a sampling syringe including a plunger cap having an air permeable filter attached to a plunger rod, which is in slidable communication with the inner wall of a syringe barrel. However, the arterial blood collected using this type of syringe is exposed to air within the barrel interior of the syringe during the blood collection. This can affect the accuracy of the arterial blood gas analysis since oxygen and carbon dioxide can migrate into or out of the arterial blood sample depending on the partial pressure of gases in the arterial blood relative to atmospheric air.
After completion of the blood sample collection, the needle is removed and the syringe containing the collected blood sample is then transported to the laboratory. Typically blood samples collected in blood collection tubes are transported through pneumatic tubes between the ward and laboratory. However, the plunger that is protruding from the syringe barrel makes handling and transportation of the syringe difficult and special care has to be taken not to dislodge the plunger thus preventing pneumatic tube transportation and increasing the time and resources required to transport and analyze the collected blood sample.
Attempts have been made to prevent the re-use of syringes by providing breakable plunger rods as part of the syringe assembly, examples of which being disclosed in U.S. Pat. No. 6,217,550 (Capes), the entire content of which is incorporated herein by reference and in U.S. Patent Publication Number US 2006/0178625 (Lim et al.), the entire content of which is also incorporated herein by reference. Such breakable plunger rod assemblies provide a breakable connection between the main body of the plunger rod and the proximal distal portion. Such breakable connections possess sufficient structural integrity to resist breakage during normal use, but break upon application of additional force. Thus, after injection of the liquid contents of the syringe into a patient or into a suitable container or device such as through the pierceable septum of a catheter connector, a user applies additional force on the thumb press of the plunger rod. This additional force causes the breakable connection to shear, mechanically disconnecting the main body of the plunger rod from the distal portion, and hence disabling further use of the syringe.
It would therefore be desirable to provide an arterial blood collection syringe or assembly and method of use thereof which enables a single-handed blood collection technique, which does not expose the collected blood to atmospheric air prior to analysis for blood gas levels and allows the plunger to be removed to facilitate easier handling and transportation of the collected sample.